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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K180225
Device Name GSI Viewer with GSI Fat Option
Applicant
GE Medical Systems SCS
283 rue de la Miniere
Buc,  FR 78530
Applicant Contact Peter Uhlir
Correspondent
GE Medical Systems, LLC
3000 North Grandview Blvd
Waukesha,  WI  53188
Correspondent Contact Kristine Schraufnagel
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/26/2018
Decision Date 04/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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